Viewing Study NCT03007316



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Study NCT ID: NCT03007316
Status: COMPLETED
Last Update Posted: 2020-11-17
First Post: 2016-12-23

Brief Title: Evaluation of Esthetics Around Immediate Implants in VIP - CT Grafted vs Non-grafted SitesRCT
Sponsor: Cairo University
Organization: Cairo University

Study Overview

Official Title: Clinical Evaluation of Soft Tissue Esthetics Around Immediate Implants in Vascularized Interpositional Periosteal Connective Tissue Grafted Versus Non-grafted Sites A Randomized Controlled Clinical Trial
Status: COMPLETED
Status Verified Date: 2020-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: An array of soft tissue augmentation techniques have been employed concomitant to implant placement as free connective tissue grafts or pedicle grafts for keratinized tissue thickening in attempt not only to augment the soft tissue for better resistance to inflammation and improved esthetic stability but to preserve buccal bone thickness as well

Results obtained from the literature were controversial regarding the need of soft tissue augmentation to curb buccal bone resorption and preserve pink esthetics Scarce literature was found that monitored the ridge alterations following implant placement

Our study will monitor the effect of soft tissue augmentation on soft tissue esthetics and buccal bone resorption during the process of remodeling in a measurable way
Detailed Description: Alveolar bone remodeling following extraction could not be prevented by immediate implant placement Soft tissue augmentaion techniques have been suggested in order to overcome the alterations of buccal bone during remodeling Nevertheless it is still inconclusive whether soft tissue augmentation procedures actually have a protective role in preserving buccal bone thickness in immediate implants

Aim is to clinically and radiographically assess the effect of soft tissue grafting on buccal bone resorption and pink esthetics around immediately placed implants in maxillary anterior teeth after 24 months following implant placement 18 non-restorable maxillary anterior teeth randomly assigned into 2 groups test group immediately placed implants with simultaneous vascular interpositional periosteal connective tissue VIP-CT grafting versus non-augmented implant sites control group Buccal bone changes were assessed at implant placement 0 and at 4912 and 24 months from baseline by specially manufactured device and at 24 months by cone beam computed tomography scans CBCT Pink esthetic score PES was evaluated at 6 9 12 and 24 months intervals Pain and satisfaction were assessed through questionnaires to the patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None